Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

This study has been completed.
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Nahidh Hasaniya, Loma Linda University
ClinicalTrials.gov Identifier:
First received: March 31, 2011
Last updated: March 23, 2016
Last verified: March 2016
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.

Condition Intervention Phase
Congenital Heart Defect
Surgery-Induced Tissue Adhesions
Device: CoSeal Surgical Spray Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

Resource links provided by NLM:

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Severity of adhesions at seven predefined sites [ Time Frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery ] [ Designated as safety issue: No ]
    Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

  • Post-operative bleeding [ Time Frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery ] [ Designated as safety issue: No ]
    Post-operative bleeding through surgical site drainage output.

  • Adhesion Burden [ Time Frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes) ] [ Designated as safety issue: No ]
    Skin to bypass time as an indicator of adhesion burden.

Secondary Outcome Measures:
  • Ease of use [ Time Frame: Data on use of CoSeal will be collected immediately following the surgery (on average 0-60 minutes postoperatively) ] [ Designated as safety issue: No ]
    Ease of use of CoSeal - graded by primary surgeon using a Likert-scale (ranging from 1 [very easy] to 5 [very difficult]).

  • Type and duration of surgery [ Time Frame: Type and duration of surgery is noted during the first 24 hours postoperatively ] [ Designated as safety issue: No ]
    Type and duration of operation and reoperation

Enrollment: 40
Study Start Date: August 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No CoSeal Surgical Spray
A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
Experimental: CoSeal Spray Group
CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
Device: CoSeal Surgical Spray Group

A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.

The dose regimen is as follows:

  • Patients weighing < 3kg will receive 1ml of CoSeal
  • Patients weighing 3-10kg will receive 1-2ml of CoSeal
  • Patients weighing >10kg will receive 2-4ml of CoSeal


Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have an acceptable surrogate capable of giving consent on the subject's behalf.
  • Pediatric patients ages 0 - 17
  • Have a cardiac disease which requires staged cardiac surgery and resternotomy
  • Non-emergent state or emergent state with sufficient time to educate and consent

Exclusion Criteria:

  • An immune system disorder
  • Unplanned reoperation
  • Known hypersensitivity to components in CoSeal
  • Patients undergoing reoperation less than 3 months after the primary surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01330433

United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92602
Sponsors and Collaborators
Loma Linda University
Baxter Healthcare Corporation
Principal Investigator: Nahidh Hasaniya, MD Loma Linda University Medical Center
Study Chair: Anees Razzouk, MD Loma Linda University Medical Center
  More Information

Responsible Party: Nahidh Hasaniya, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01330433     History of Changes
Other Study ID Numbers: 5110074 
Study First Received: March 31, 2011
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tissue Adhesions
Heart Defects, Congenital
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 23, 2016